ESC Congress 2016 - 28

clINIcAl TRIAl HIgHlIgHTs ENSURE-AF: Edoxaban Safe, Similar Efficacy as Warfarin for AF Cardioversion months scheduled for electrical cardioversion and anticoagulation therapy to once-daily edoxaban (given at least 2 hours before cardioversion) or enoxaparin/warfarin (INR 2.0-3.0). Three stratifications were also undertaken: 1) transthoracic echocardiography (TEE)-guided or non-TEE-guided cardioversion; 2) prior use of anticoagulants; and 3) edoxaban dose (60 mg QD or 30 mg QD). The lower dose of edoxaban is for patients with reduced renal function (creatinine clearance ≥ 15 mL/min and ≤ 50 mL/min), with low body weight (≤ 60 kg), or taking a potent P-glycoprotein inhibitor. The baseline characteristics are outlined in Table 1. The mean age was 64 years, most were men (66%), and the mean CHA2DS2-VASc score was 2.6. For both treatment arms, the time to cardioversion was 2 days in the TEE-guided stratum and 23 days for the non-TEEguided stratum. Of note, enoxaparin was used during the run-in, but was stopped when the INR was > 2.0, yielding a 70.8% time in therapeutic range on warfarin. For the primary efficacy composite outcome of stroke, systemic embolic event, myocardial infarction, and cardiovascular mortality at 56 days post cardioversion, a trend was seen toward a reduction (0.5% with edoxaban vs 1.0% with enoxaparin/VKA; OR, 0.46, 95% CI, 0.12 to 1.43) in ischemic events in the total population, and also in both TEE strata (Figure 1). Written by Mary Mosley The largest prospective randomized controlled trial of anticoagulation in patients with atrial fibrillation (AF) undergoing electrical cardioversion showed that the direct oral anticoagulant edoxaban was safe and had a similar effect on the primary outcome as the standard approach of enoxaparin combined with a vitamin K antagonist (VKA), according to results presented by Andreas Goette, MD, St. Vincenz Hospital Paderborn and University Hospital Magdeburg, Germany. The results of the ENSURE-AF study were simultaneously published [Goette A et al. Lancet. 2016]. Data from post hoc analyses of the four non-VKA oral anticoagulants (NOACs) [Renda G et al. Am J Med 2016] and the randomized X-VERT trial [Cappato R et al. Eur Heart J. 2014] have suggested NOACs could be a safe alternative to the currently recommended VKAs, which are associated with inter- and intrapatient variability and require monitoring of the INR target range. The open-label, phase 3b, international study randomized 2199 patients with AF for ≥ 48 hours but ≤ 12 Table 1. Baseline Characteristics of Patients in ENSURE-AF Total by Treatment Age (y), mean Male, n (%) TEE Stratum Non-TEE Stratum Edoxaban (n = 1095) Enoxaparin + Warfarin (n = 1104) Edoxaban (n = 589) Enoxaparin + Warfarin (n = 594) Edoxaban (n = 506) Enoxaparin + Warfarin (n = 510) 64.3 64.2 64.9 64.5 63.6 63.8 721 (65.8) 722 (65.4) 385 (65.4) 389 (65.5) 336 (66.4) 333 (65.3) 2 BMI (kg/m ), mean 30.6 30.7 30.4 30.4 31.0 31.0 CHA 2DS2-VASc, mean 2.6 2.6 2.7 2.7 2.5 2.5 Paroxysmal AF (≤ 7 days), n (%) 208 (19.0) 207 (18.8) 138 (23.4) 132 (22.2) 70 (13.8) 75 (14.7) Persistent AF (> 7 days, < 1 y), n (%) 887 (81.0) 890 (80.6) 451 (76.6) 458 (77.1) 436 (86.2) 432 (84.7) Anticoagulant experienced, n (%) 791 (72.2) 808 (73.2) 426 (72.3) 440 (74.1) 365 (72.1) 368 (72.2) Congestive heart failure 476 (43.5) 484 (43.8) 258 (43.8) 259 (43.6) 218 (43.1) 225 (44.1) Coronary artery disease 181 (16.5) 197 (17.8) 89 (15.1) 111 (18.7) 92 (18.2) 86 (16.9) Diabetes 218 (19.9) 197 (17.8) 115 (19.5) 105 (17.7) 103 (20.4) 92 (18.0) Medical history, n (%) AF, atrial fibrillation; BMI, body mass index; TEE, transthoracic echocardiography. Source: Goette A et al. Lancet. 2016. 28 October 2016 www.escardio.org/ESCcongressinreview http://www.escardio.org/ESCcongressinreview

Table of Contents for the Digital Edition of ESC Congress 2016